Riociguat 1mg Tablets — Generic Adempas® 1mg | Order Online

Riociguat 1mg Tablets are a prescription medicine containing riociguat 1mg as the active ingredient and the generic equivalent of Adempas® 1mg, the reference brand developed by Bayer. Riociguat is a first-in-class soluble guanylate cyclase (sGC) stimulator — the only medicine in its class — approved for the treatment of both pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). The 1mg strength is the standard starting dose for most patients, taken three times daily and uptitrated every two weeks to the individual patient’s optimal dose, up to the maximum of 2.5mg three times daily. Generic riociguat 1mg tablets are available internationally across the USA, UK, Australia, UAE, Germany, France, Russia, South Korea and worldwide.

Product Information

What Is Riociguat 1mg Used For?

Riociguat 1mg is the standard initiation dose for both approved indications — PAH and CTEPH — in patients whose blood pressure and clinical profile do not require the lower 0.5mg starting dose.

Pulmonary Arterial Hypertension (PAH — WHO Group 1)
Riociguat 1mg TID is the standard starting dose for PAH patients in WHO functional class II–III. Treatment aims to improve exercise capacity, WHO functional class and delay clinical worsening. The pivotal PATENT-1 trial demonstrated that riociguat — titrated up to 2.5mg TID — significantly improved 6-minute walk distance (6MWD), pulmonary vascular resistance (PVR), WHO functional class and time to clinical worsening versus placebo. The open-label PATENT-2 extension study showed sustained long-term benefits.

Riociguat 1mg TID is used both as:

• Monotherapy in treatment-naïve PAH patients
• Add-on therapy in patients already receiving an endothelin receptor antagonist (ERA) such as macitentan or bosentan

Chronic Thromboembolic Pulmonary Hypertension (CTEPH — WHO Group 4)
Riociguat 1mg TID is the standard starting dose for CTEPH patients with:

• Inoperable CTEPH — where pulmonary endarterectomy (PEA) surgery is not possible due to inaccessible thrombi or comorbidities
• Persistent or recurrent CTEPH — residual pulmonary hypertension following PEA surgery

The pivotal CHEST-1 trial demonstrated significant improvements in 6MWD, PVR, WHO functional class and NT-proBNP in CTEPH patients on riociguat versus placebo. Riociguat remains the only oral medicine with a specific regulatory approval for CTEPH.

When is 1mg used vs 0.5mg?
Riociguat 1mg TID is the starting dose for the majority of patients. The lower 0.5mg TID starting dose is reserved for patients at heightened hypotension risk — those with low baseline systolic blood pressure, significant volume depletion or concurrent vasodilatory therapy. The treating specialist determines the appropriate starting dose for each patient.

United States: Adempas® (riociguat) is FDA-approved for PAH and CTEPH. Available only through the Adempas REMS programme. Generic riociguat 1mg is available from multiple manufacturers.

United Kingdom / EU: Riociguat (Adempas®) is EMA-approved for PAH (WHO FC II–III) and inoperable or post-PEA persistent/recurrent CTEPH.

Australia: Riociguat 1mg Australia — subject to TGA registration and ARTG listing. PBS subsidisation for PAH and CTEPH — confirm eligibility with your specialist.

UAE / Gulf: Subject to UAE Ministry of Health registration. Consult a UAE-licensed specialist for current riociguat 1mg UAE availability.

Germany: Riociguat 1mg Filmtabletten are available as Adempas® 1mg and as generic riociguat 1mg products. All prescription-only (rezeptpflichtig).

France: Riociguat 1mg comprimés pelliculés available as Adempas® and generics, subject to HAS reimbursement.

Russia: Риоцигуат 1 мг available as Адемпас® 1 мг, requiring a valid prescription.

South Korea: 리오시구아트 1mg registered for prescription use per MFDS-approved labeling.

Always follow the prescribing information applicable to your country and the guidance of your licensed PAH/CTEPH specialist.

How Riociguat 1mg Works

Riociguat has a unique dual mechanism of action that distinguishes it from all other pulmonary hypertension therapies and from PDE-5 inhibitors which operate on the same nitric oxide / cGMP pathway:

1. Direct sGC stimulation — independent of nitric oxide
Riociguat binds directly to soluble guanylate cyclase (sGC) and stimulates cGMP production even in the absence of nitric oxide. In PAH and CTEPH, endogenous nitric oxide production is impaired — riociguat bypasses this deficit and activates the enzyme directly.

2. Nitric oxide sensitisation
Riociguat simultaneously increases sGC sensitivity to available endogenous nitric oxide, amplifying vasodilatory signalling even at low NO concentrations — a synergistic effect that maximises cGMP production.

Increased cGMP production causes:

• Pulmonary vasodilation — relaxation of pulmonary vascular smooth muscle
• Reduced pulmonary vascular resistance (PVR) — relieving the haemodynamic burden on the right ventricle
• Anti-proliferative effects — inhibiting vascular smooth muscle cell proliferation and remodelling
• Anti-fibrotic effects — reducing fibrotic changes in pulmonary vessel walls
• Platelet inhibition — contributing to anti-thrombotic effects relevant in CTEPH

Riociguat vs PDE-5 inhibitors:
Both drug classes increase cGMP in pulmonary vascular smooth muscle — but through opposite mechanisms. Riociguat stimulates cGMP production; PDE-5 inhibitors prevent its breakdown. Combining them produces dangerous additive hypotension and is absolutely contraindicated.

Riociguat Titration Schedule — 1mg as the Standard Start

If systolic BP drops below 95 mmHg with hypotension symptoms at any stage, dose is reduced by 0.5mg TID. If initiated at 0.5mg TID, uptitration reaches 1mg TID at weeks 3–4 and follows the same schedule thereafter. All dose adjustments are managed exclusively by the treating specialist.

Riociguat 1mg in Combination PAH Therapy

Riociguat 1mg TID can be used as part of combination PAH therapy targeting multiple disease pathways:

• ERA + sGC stimulator: Riociguat combined with macitentan or bosentan — targets both the endothelin pathway and the nitric oxide/cGMP pathway simultaneously. This is a supported and frequently used combination in PAH management.
• Prostacyclin + sGC stimulator: Riociguat combined with prostacyclin analogues or selexipag — targets three PAH pathways simultaneously (triple combination therapy).

Combination never permitted:

• Riociguat + PDE-5 inhibitors (sildenafil, tadalafil, vardenafil, avanafil) — absolutely contraindicated
• Riociguat + nitrates or nitric oxide donors — contraindicated

Generic Riociguat 1mg vs Adempas® 1mg

Adempas® 1mg is the originator brand containing riociguat 1mg. Generic riociguat 1mg tablets contain the same active ingredient at the same strength but may differ in inactive ingredients, tablet appearance, packaging and manufacturer. PAH and CTEPH are specialist-managed conditions — consult your specialist before switching between branded and generic riociguat products.

Key Safety Information — Riociguat 1mg

Teratogenicity — Absolute Pregnancy Contraindication
Riociguat is highly teratogenic and absolutely contraindicated in pregnancy at all doses including 1mg. Requirements for women of childbearing potential:

• Negative pregnancy test before initiation
• Reliable contraception throughout treatment and for one month after stopping
• Monthly pregnancy tests during treatment
• In the USA — mandatory enrolment in the Adempas REMS programme

Hypotension
Riociguat 1mg TID causes vasodilation and can produce clinically significant hypotension, particularly:

• At initiation and during each uptitration step
• When combined with antihypertensive agents or other vasodilators
• In patients who are volume-depleted or have low baseline blood pressure

Systolic blood pressure must be assessed before each dose increase. If systolic BP falls below 95 mmHg with symptoms, the dose must be reduced.

Contraindications

• Pregnancy — absolute contraindication
• Concurrent PDE-5 inhibitors (sildenafil, tadalafil, vardenafil, avanafil) — absolutely contraindicated
• Concurrent nitrates or nitric oxide donors — contraindicated
• Severe hepatic impairment (Child-Pugh C)
• Severe renal impairment (creatinine clearance <15 ml/min) or dialysis
• Pulmonary hypertension associated with idiopathic interstitial pneumonias (PH-IIP)
• Known hypersensitivity to riociguat or excipients

Drug Interactions

• PDE-5 inhibitors — absolutely contraindicated (dangerous additive hypotension)
• Nitrates and nitric oxide donors — contraindicated
• Strong CYP3A4 and P-gp inhibitors (ketoconazole, itraconazole, ritonavir) — significantly increase riociguat exposure; avoid
• CYP3A4 inducers (rifampicin, carbamazepine, phenytoin, St John’s Wort) — significantly reduce riociguat efficacy; avoid
• Antacids containing aluminium/magnesium hydroxide — reduce riociguat absorption; separate administration by at least 1 hour
• Smoking — substantially reduces riociguat plasma concentrations; dose adjustment may be needed on smoking cessation

Pulmonary Veno-Occlusive Disease (PVOD)
If pulmonary oedema develops, PVOD should be considered and riociguat discontinued. Riociguat is not indicated for PH associated with PVOD.

Bleeding
Riociguat may increase bleeding risk, particularly in patients on anticoagulants. Monitor for signs of bleeding during treatment.

Always read the patient information leaflet and prescribing information applicable to your country.

Riociguat 1mg — Availability by Country

Frequently Asked Questions — Riociguat 1mg

What is Riociguat 1mg used for?
Riociguat 1mg is the standard starting dose for the treatment of pulmonary arterial hypertension (PAH — WHO Group 1) and chronic thromboembolic pulmonary hypertension (CTEPH — WHO Group 4, inoperable or post-surgical persistent/recurrent). It is taken three times daily and titrated every two weeks up to the maximum dose of 2.5mg TID based on blood pressure and tolerability.

Is Riociguat 1mg the generic for Adempas® 1mg?
Yes. Adempas® 1mg is the originator brand. Generic riociguat 1mg film-coated tablets contain the same active ingredient and strength. Inactive ingredients, appearance and manufacturer may differ.

What is the difference between Riociguat 0.5mg and 1mg?
Riociguat 1mg TID is the standard starting dose for most patients. Riociguat 0.5mg TID is reserved for patients at higher risk of hypotension — those with low baseline blood pressure, volume depletion or concurrent vasodilatory therapy. Both are uptitrated to the same maximum dose of 2.5mg TID. The treating specialist determines the appropriate starting dose.

How long does Riociguat 1mg titration take to reach maximum dose?
Starting at 1mg TID, titration to the maximum 2.5mg TID dose takes approximately 6–8 weeks, with dose increases every 2 weeks. Each increase requires systolic BP above 95 mmHg and absence of hypotension symptoms. Not all patients reach the maximum dose — the individual optimal dose varies.

Why can’t Riociguat 1mg be combined with Sildenafil or Tadalafil?
Riociguat increases cGMP production by stimulating sGC; PDE-5 inhibitors increase cGMP by preventing its breakdown. Combining both mechanisms produces dangerous additive hypotension. This combination is absolutely contraindicated regardless of dose.

Can Riociguat 1mg be used with Macitentan?
Yes. Riociguat and macitentan target different PAH pathways — the nitric oxide/cGMP pathway and the endothelin pathway respectively — and can be used together. Monitor blood pressure when combining vasodilatory medicines.

Does smoking affect Riociguat 1mg?
Yes significantly. Smoking induces CYP1A1 and reduces riociguat plasma concentrations by approximately 50–60%. Smokers may require higher titration doses. Patients who stop smoking during treatment may experience increased riociguat exposure and require dose reduction — monitor blood pressure closely after smoking cessation.

What is the Adempas REMS programme?
In the USA, riociguat (Adempas® and generics) is only available through the REMS programme due to teratogenicity risk. Prescribers, pharmacies and female patients of childbearing potential must be enrolled. Monthly pregnancy testing and reliable contraception are mandatory requirements.

Is Riociguat 1mg approved for CTEPH as well as PAH?
Yes. Riociguat is the only oral medicine with regulatory approval for both PAH (WHO Group 1) and CTEPH (WHO Group 4 — inoperable or post-PEA persistent/recurrent). This dual approval is a unique clinical distinction of riociguat among all PAH/CTEPH therapies.

Can I buy Riociguat 1mg tablets online?
Riociguat 1mg is prescription-only in all major markets. In the USA it is only available through the Adempas REMS programme. PAH and CTEPH are serious, specialist-managed conditions — riociguat must be prescribed by and used under the supervision of a licensed PAH/CTEPH specialist.

Is Riociguat 1mg available in Australia?
Riociguat 1mg products are registered on the ARTG. PBS subsidisation depends on indication and eligibility criteria. Confirm current PBS status with your PAH/CTEPH specialist or pharmacist.

What is Riociguat 1mg in Germany?
Riociguat 1mg Filmtabletten are available in Germany as Adempas® 1mg and as generic riociguat 1mg products from multiple manufacturers. All are prescription-only (rezeptpflichtig) and restricted to specialist prescribing for PAH and CTEPH.

Medical Disclaimer

This information is provided for educational and commercial reference purposes only and is not a substitute for professional medical advice, diagnosis or treatment. Riociguat 1mg is a prescription-only medicine for serious conditions — pulmonary arterial hypertension and chronic thromboembolic pulmonary hypertension — with important risks including teratogenicity, hypotension and dangerous interactions with PDE-5 inhibitors and nitrates. In the USA it is only available through the Adempas REMS programme. It must be prescribed and managed by a qualified PAH/CTEPH specialist. Always use according to the applicable prescribing information and the advice of a licensed healthcare professional in your country.

Last Updated: September 25, 2026